- Digital CBT recommended for children and young people with mild depression in draft guidance.
- NICE has also recommended the following:
- Encorafenib with binimetinib for some people with melanoma (final draft guidance)
- Nivolumab for adjuvant treatment of resected stage III and IV melanoma in CDF
- Senza spinal cord stimulation system for chronic neuropathic pain
- Platelet-rich plasma injections for knee osteoarthritis, only to be used under special arrangements
- Bronchoscopic thermal vapour ablation for upper-lobe emphysema, for research purposes only (draft guidance).
- Guideline published on diagnosing foetal alcohol spectrum disorder.
- Updated guidance published on the use of combined hormonal contraceptives.
- Cross-government suicide prevention plan published.
- Risk of avian flu: advice published for travellers over Chinese New Year.
- Plan to eliminate hepatitis C backed by High Court.
- TB prevention, care and control guidance published.
- Guideline published for the management and transfer of patients with ruptured abdominal aortic aneurysm to a specialist vascular centre.
- Serious Shortage Protocols: draft legislation proposed.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
DIGITAL CBT RECOMMENDED FOR CHILDREN AND YOUNG PEOPLE WITH MILD DEPRESSION IN DRAFT GUIDANCE
NICE has published draft guidance which recommends digital cognitive behavioural therapy (digital CBT, also known as computer CBT), as a first-line treatment for children and young people with mild depression. Digital CBT can be offered to children or young people, age five to eighteen, with continuing symptoms of mild depression who do not have other significant health conditions or suicidal thoughts. Group CBT, group interpersonal psychotherapy and group mindfulness are also recommended as first-line treatments and the NICE committee highlighted the choice of treatment should be based on clinical need and patient and carer preferences wherever possible. The draft recommendations from this fast-tracked update were sparked by a recent trial looking at psychological therapies in young people. The guidance is now out for consultation and the closing date for comments is 20 February 2019.
ENCORAFENIB WITH BINIMETINIB RECOMMENDED FOR SOME PEOPLE WITH MELANOMA IN FINAL DRAFT GUIDANCE
Encorafenib (Braftovi) with binimetinib (Mektovi) has been recommended as an option for the treatment of advanced (unresectable or metastatic) BRAF V600 mutation-positive melanoma, that cannot be removed surgically or that has spread to nearby organs. Clinical trial results showed that encorafenib and binimetinib had longer rates of median overall survival (33.6 months) compared to vemurafenib (16.9 months), which is already recommended by NICE. When compared indirectly, this drug combination also appeared to be as effective as dabrafenib with trametinib, which were recommended in October 2018. The treatment will be available at a confidential discounted price agreed between NHS England and the company.
NIVOLUMAB RECOMMENDED FOR ADJUVANT TREATMENT OF RESECTED STAGE III AND IV MELANOMA IN CDF
NICE has published final guidance which recommends Nivolumab (Opdivo) for use within the Cancer Drugs Fund (CDF) as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease. It is recommended only if the conditions in the managed access agreement are followed. Clinical evidence from CheckMate 238, an ongoing randomised trial, shows that nivolumab improves recurrence-free survival compared with ipilimumab. There are currently no trials comparing nivolumab with routine surveillance, which is the standard of care in the NHS. An indirect treatment comparison using ipilimumab as a common comparator showed that nivolumab is likely to improve recurrence-free survival compared with routine surveillance. However, the committee found that there is currently no reliable clinical evidence to show that it improves overall survival. This means that the clinical and cost effectiveness of adjuvant nivolumab is uncertain, therefore more evidence is needed to address the clinical uncertainties. NICE says that longer follow‑up data from CheckMate 238 on how long people live and how long people live without their disease coming back would help to address these uncertainties.
SENZA SPINAL CORD STIMULATION SYSTEM RECOMMENDED FOR CHRONIC NEUROPATHIC PAIN
NICE has published final guidance recommending the Senza spinal cord stimulation (SCS) system as an option for treating chronic neuropathic back or leg pain that has not improved after surgery. Senza SCS for delivering HF10 therapy should be considered for patients:
- with residual chronic neuropathic back or leg pain (at least 50 mm on a 0 mm to 100 mm visual analogue scale) at least six months after back surgery despite conventional medical management and
- who have had a successful trial of stimulation as part of a wider assessment by a multidisciplinary team.
The evidence shows that Senza is at least as effective as low-frequency SCS in reducing pain and functional disability in people with this condition and avoids the sensation of paraesthesia which can disrupt sleep and daily activities. The committee noted less certainty of the additional benefits of using Senza compared with low frequency SCS in people with neuropathic pain of other causes, or in people who have not had previous back surgery. However, the guidance recommends that Senza may be considered as an option for these people. The guidance also recommends that clinicians implanting SCS devices, including Senza, should submit outcome data to the UK Neuromodulation Registry.
PLATELET-RICH PLASMA INJECTIONS FOR KNEE OSTEOARTHRITIS RECOMMENDED FOR USE UNDER SPECIAL ARRANGEMENTS
NICE has published evidence-based recommendations for platelet-rich plasma injections for knee osteoarthritis in adults. Current evidence on platelet-rich plasma injections for knee osteoarthritis raises no major safety concerns. However, the evidence on efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Clinicians wishing to give platelet-rich plasma injections for knee osteoarthritis should:
- Inform the clinical governance leads in their NHS trusts.
- Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
- Audit and review clinical outcomes of all patients having platelet-rich plasma injections for knee osteoarthritis, including details of the methods used to prepare and administer the platelet-rich plasma injections. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
NICE says further research should be in the form of randomised controlled trials with medium- to long-term follow‑up, including validated measures of knee function and patient-reported outcomes.
BRONCHOSCOPIC THERMAL VAPOUR ABLATION FOR UPPER-LOBE EMPHYSEMA RECOMMENDED FOR RESEARCH PURPOSES ONLY
Current evidence on the safety and efficacy of bronchoscopic thermal vapour ablation for upper-lobe emphysema is inadequate in quantity and quality, according to NICE draft guidance. Further research should evaluate safety and efficacy in the short and long-term and include details of patient selection It is therefore recommended that the procedure should only be used in the context of research. The guidance is now open for public consultation until 21 February 2019.
SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK
GUIDELINE PUBLISHED ON DIAGNOSING FOETAL ALCOHOL SPECTRUM DISORDER
The Scottish Intercollegiate Guidelines Network (SIGN) has developed and published a guideline which provides evidence-based recommendations on measurement of alcohol consumption in pregnancy and consensus-based recommendations on:
- identification of children at risk of foetal alcohol syndrome disorder (FASD)
- criteria for diagnosis and use of FASD as a descriptor
- the medical assessment
- physical examination
- sentinel facial features
- neurodevelopmental assessment
- the multidisciplinary assessment team
- special considerations in the neurodevelopmental assessment
- management and follow up of children and young people affected by prenatal alcohol exposure (PAE).
Detailed treatment options for individuals affected by PAE are not included.
FACULTY OF SEXUAL AND REPRODUCTIVE HEALTHCARE
UPDATED GUIDANCE PUBLISHED ON THE USE OF COMBINED HORMONAL CONTRACEPTIVES
The Faculty of Sexual and Reproductive Healthcare has published evidence-based recommendations and good practice points for health professionals on the use of combined hormonal contraceptives (i.e. the combined oral contraceptive pill, transdermal patch and combined vaginal ring) currently available in the UK. The updated guidance recommends that women can safely take fewer (or no) hormone-free intervals to avoid monthly bleeds, cramps and other symptoms (see OnMedica article). The updated guideline also states that consultations about combined hormonal contraception (CHC) do not necessarily have to be face-to-face, online CHC provision is possible, and that at first consultation, many women can safely be prescribed a one-year supply of CHC instead of the current three-month supply.
DEPARTMENT OF HEALTH AND SOCIAL CARE
CROSS-GOVERNMENT SUICIDE PREVENTION PLAN PUBLISHED
The Department of Health and Social Care has published the first cross-government suicide prevention plan. The plan has a focus on how social media and the latest technology – such as predictive analytics and artificial intelligence – can identify those at risk of suicide. The plan commits the government to improving data held on causes of death among veterans to better understand the triggers that can lead someone to take their own life, such as debt and gambling addiction. It also includes greater focus on addressing the increase in suicide and self-harm among young people, while social media companies will be asked to take more responsibility for online content that promotes methods of suicide and self-harm. Other parts of the plan include:
- every local authority putting an effective suicide prevention plan in place
- ensuring every mental health trust has a zero-suicide ambition plan for mental health inpatients by the end of 2019
- every prison putting actions in place to reduce suicides and self-harm and improve staff awareness and training
- addressing the specific needs of the highest risk groups, including middle-aged men, with £25 million funding
- improving research on things that can be linked to suicide, such as debt and gambling addiction.
The plan supports the national suicide prevention strategy, following recommendations from the Health Select Committee’s inquiry into suicide prevention in 2016.
PUBLIC HEALTH ENGLAND
RISK OF AVIAN FLU: ADVICE PUBLISHED FOR TRAVELLERS OVER CHINESE NEW YEAR
Public Health England (PHE) has warned that travellers should be aware of the risk of avian flu when travelling to China during the annual Chinese Lunar New Year or Spring Festival. Human cases of avian influenza have recently been reported in China, and historically there have been more cases at this time of year. Cases have originated from several provinces and municipalities across Mainland China, and there has been a small number of cases among Hong Kong SAR and Taiwan residents who have travelled to mainland China. The majority of reported human cases in China have had close contact with wild birds or poultry. Although the risk is very low, PHE and the National Travel Health Network and Centre are reminding UK travellers to protect themselves from avian flu by minimising exposure to wild birds and poultry.
PLAN TO ELIMINATE HEPATITIS C BACKED BY HIGH COURT
NHS England’s plan to eliminate Hepatitis C in England by 2025 is back on track after all aspects of a High Court challenge by pharmaceutical company AbbVie were dismissed. The NHS’s single largest medicines procurement, a deal worth almost £1 billion over five years, was launched in April last year but contract start dates had to be delayed by six months after legal action by AbbVie. AbbVie claimed that not all bidders had been treated fairly in the procurement process, but the High Court rejected this claim. The procurement was designed to achieve an affordable price for the drugs so that NHS England could plan to eliminate hepatitis C (see OnMedica article). The Hepatitis C procurement is the latest in a series of ‘smart deals’ the NHS has delivered to drive value for the taxpayer and benefits for patients.
ROYAL COLLEGE OF NURSING
TB PREVENTION, CARE AND CONTROL GUIDANCE PUBLISHED
The Royal College of Nursing has published guidance for clinical and non-clinical staff involved in the management and care of patients with Tuberculosis (TB). It aims to promote standardisation of protocols and procedures, ensure accountability for delivery and establish clear performance measures through cohort review. The tool is consistent with existing guidance for professionals working in the field of TB in the UK which provide a sound framework for clinical management and commissioning.
ROYAL COLLEGE OF EMERGENCY MEDICINE
GUIDELINE PUBLISHED FOR THE MANAGEMENT AND TRANSFER OF PATIENTS WITH RUPTURED ABDOMINAL AORTIC ANEURYSM TO A SPECIALIST VASCULAR CENTRE
The Royal College of Emergency Medicine has published a guideline which aims to ensure patients with a clinical diagnosis of ruptured abdominal aortic aneurysm (rAAA) equity of access to a specialist vascular centre for expert assessment and intervention. If not already present, emergency physicians and vascular surgeons should work collaboratively to develop region-wide protocols to facilitate access to this standard of care. Simultaneously, this guideline should assist the emergency physician in the assessment, resuscitation and timely preparation for transfer of the patient with a clinical diagnosis of rAAA, if this diagnosis is made in a hospital without suitable vascular facilities. This guideline should optimise and standardise the management of patients arriving in vascular centres, ensuring patients who would benefit from surgery are transferred without delay and those not suitable for surgery, and likely to die, are palliated appropriately.
SERIOUS SHORTAGE PROTOCOLS: DRAFT LEGISLATION PROPOSED
The Pharmaceutical Services Negotiating Committee (PSNC) has reported that draft legislation on Serious Shortage Protocols (SSPs) has been laid before parliament and should come into force in early February 2019. This follows consultation between the Department of Health and Social Care (DHSC) and stakeholders, including PSNC and other pharmacy representative bodies. SPPs will give pharmacies the ability to dispense less medicine, a different strength or pharmaceutical form of the medicine or an alternative medicine to that prescribed; following appropriate discussions with the patient. SSPs are part of the work being carried out by government and the NHS in case there is a no-deal exit from the EU. However, PNSC has also stated that consideration should be given to the current Drug Tariff concession pricing system, in particular that there is equitable reimbursement where the concession price imposed by DHSC is significantly lower than the market price of the medicine, and also warns that the use of branded generics may adversely affect the supply of medicines.